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FDA 510(k)

ULTRALON POWDER FREE LATEX SURGICAL GLOVE

K-Number: K973699 · 1997-12-16

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1997-12-16
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRALON POWDER FREE LATEX SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K973699. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRALON POWDER FREE LATEX SURGICAL GLOVE?

ULTRALON POWDER FREE LATEX SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K973699.

When did ULTRALON POWDER FREE LATEX SURGICAL GLOVE receive FDA 510(k) clearance?

ULTRALON POWDER FREE LATEX SURGICAL GLOVE received FDA 510(k) clearance on 1997-12-16, under 510(k) number K973699.

Who is the listed applicant for ULTRALON POWDER FREE LATEX SURGICAL GLOVE?

The FDA 510(k) record lists Johnson & Johnson Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRALON POWDER FREE LATEX SURGICAL GLOVE?

The FDA product code for ULTRALON POWDER FREE LATEX SURGICAL GLOVE is KGO.

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Other records listing Johnson & Johnson Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEM

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Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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